2024-515119-23-00招募中2 期
A phase Ib/II trial evaluating the combination of TG4001 and avelumab in patients with HPV-16 positive recurrent or metastatic malignancies
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Transgene
- 入组人数
- 142
- 试验地点
- 17
- 主要终点
- Phase II part 1: overall response rate according to RECIST 1.1
研究概览
简要总结
Phase Ib objective: To evaluate the safety and tolerability of the combination of TG4001 plus avelumab in patients with recurrent or metastatic HPV-16 positive advanced malignancies. Phase II part 1 objective: To evaluate the efficacy of TG4001 combined to avelumab in terms of Overall Response Rate (ORR) by using RECIST 1.1 in patients with recurrent or metastatic (R/M) HPV-16 positive advanced malignancies including oropharyngeal squamous cell carcinoma of head and neck. Phase II part 2 objective: To compare the Progression-Free Survival (PFS) of TG4001 in combination with avelumab vs avelumab alone in patients with recurrent or metastatic (R/M) HPV-16 positive advanced malignancies and without liver metastases at baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Phase II part 2
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Female or male patients, aged at least 18 years (no upper limit of age)
- •Negative blood pregnancy test at screening for women of childbearing potential
- •Highly effective contraception for both male and female patients if the risk of conception exists during the study period and for 3 months after the last study treatment administration
- •ECOG PS 0 or 1
- •Life expectancy of at least 3 months
- •Phase Ib and Phase II part 1: Patients with histologically or cytologically documented metastatic or refractory/recurrent HPV-16 + cancer (cervical, vulvar, vaginal, penile, anal cancers and oropharyngeal squamous cell carcinoma of head and neck); Phase II part 2: Patients with HPV-16+ cancers including cervical, vulvar, vaginal, penile, and anal cancer
- •Disease MUST not be amenable to curative surgery resection or curative radiotherapy with documented disease progression
- •Prior therapy: Phase Ib and Phase II part 1: Patients MAY have received up to 2 prior lines of systemic chemotherapy for the management of metastatic or recurrent disease; for SCCHN, patients MUST have previously been exposed to platinum-based therapy, either as part of definitive chemoradiation OR as first line systemic treatment for metastatic disease which may include cetuximab. Patients with recurrence/progression within 6 months of prior multimodal therapy using platinum-based therapy are eligible. Patients with cervical cancer may have undergone surgery and/or received definitive radiation or chemo-radiation therapy for localized disease. Phase II part 2: - No more than one prior systemic treatment for recurrent /metastatic disease - Prior treatment for recurrent or metastatic disease is not required for: o Patients with recurrence/progression within 6 months after completion of prior multimodal therapy for localized or locally advanced disease o Patients who are unsuitable for platinum-based therapy o Patients who refuse chemotherapy or other standard therapies for the treatment of metastatic or recurrent disease
- •For patients with hepatic metastases - no more than 3 hepatic lesions in total (target and non-target lesions) - maximum size of hepatic target disease ≤ 30 mm according to RECIST 1.1
- •At least one measurable lesion by CT scan according to RECIST 1.
- •Adequate hematological, hepatic and renal function
排除标准
- •Prior exposure to cancer immunotherapy including cancer vaccines, any antibody/drug targeting T cell co-regulatory proteins (immune checkpoints)
- •Patients with history of interstitial lung disease
- •Patients with active, known, or suspected auto-immune disease or immunodeficiency, except type I diabetes mellitus, hypothyroidism only requiring hormone replacement or skin disorders (such as vitiligo, psoriasis) not requiring systemic treatment
- •Significant chronic or acute infections including SARS-CoV-2 (COVID19) PCR positive testing
- •Clinically significant (that is, active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction (< 6 months prior to enrollment), unstable angina pectoris, congestive heart failure (New York Heart Association Classification Class ≥ II), or serious uncontrolled cardiac arrhythmia requiring medication/active intervention
- •History of uncontrolled intercurrent illness including but not limited to: - Hypertension uncontrolled by standard therapies (not stabilized to 150/90 mmHg or lower) - Uncontrolled diabetes (e.g., hemoglobin A1c ≥ 8%)
- •Patients under chronic treatment with systemic corticosteroids or other immunosuppressive drugs for a period of at least 4 weeks and whose treatment was not stopped 2 weeks prior to the first study treatment, with the exception of patients with adrenal insufficiency who may continue corticosteroids at physiological replacement dose, equivalent to ≤ 10 mg prednisone daily. Steroids with no or minimal systemic effect (topical, inhalation) are allowed
- •Patients with CNS metastases except those with brain metastases treated locally and clinically stable during 4 weeks prior to start of study treatment, and those without ongoing neurological symptoms that are related to the brain localization of the disease
- •Other active malignancy requiring concurrent systemic intervention
- •Patients with previous malignancies other than the target malignancy to be investigated in this trial (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period
- •Patient with any organ transplantation, including allogeneic stem cell transplantation
- •Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI-CTC V4.03), any history of anaphylaxis, or uncontrolled asthma
- •Any known allergy or reaction to eggs, gentamycin or attributed to compounds of similar chemical or biological composition to therapeutic vaccines/immunotherapeutic products
- •Any known allergy or reaction to any component of anti-PD-L1/PD-1 or its excipients
结局指标
主要结局
Phase II part 1: overall response rate according to RECIST 1.1
Phase II part 1: overall response rate according to RECIST 1.1
Phase II part 2: progression-free survival according to RECIST 1.1
Phase II part 2: progression-free survival according to RECIST 1.1
Phase Ib: safety and tolerability
Phase Ib: safety and tolerability
次要结局
- Phase Ib: Overall response rate by using RECIST 1.1 and overall safety profile
- Phase Ib and phase II part 2: Overall response rate by using RECIST 1.1
- Phase Ib and phase II part 1: Progression Free Survival (PFS)
- Overall Survival (OS)
- Duration of Response (DoR)
- Overall safety profile
- Percentage of patients with liver metastases at baseline who have disease progression at D43 (phase II part 2)
研究者
Transgene Medical Affairs
Scientific
Transgene
研究点 (17)
Loading locations...
相似试验
招募中
1 期
A study of TG4001 and avelumab cancer immunotherapies in advanced HPV-induced malignanciesCTIS2024-515119-23-00Transgene142
进行中（未招募）
1 期
A study of TG4001 and avelumab cancer immunotherapies in advanced HPV-induced malignanciesHPV-16 positive recurrent or metastatic malignancies including oropharyngeal squamous cell carcinoma of head and neck, cervical cancer, vulvar cancer, vaginal cancer, penile cancer, anal cancerMedDRA version: 20.0Level: PTClassification code 10061424Term: Anal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10034299Term: Penile cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10008229Term: Cervical cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10046888Term: Vaginal cancer NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10047777Term: Vulvar cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-002799-28-GBTransgene52
进行中（未招募）
1 期
Study the effects of azacitidine and lenalidomide combination therapy in patients with acute myeloid leukemiaMedDRA version: 21.0Level: LLTClassification code 10024289Term: Leukaemia acuteSystem Organ Class: 100000004864ACUTE MYELOID LEUKEMIAEUCTR2015-001767-40-ITAZIENDA OSPEDALIERA OSPEDALI RIUNITI MARCHE NORD66
已完成
不适用
A prospective phase I/II trial of the combination of ixazomib citrate, rituximab and dexamethasone in patients wit relapsed or rogressive Waldenström’s macroglobiulinemia. A HOVON / Greek Myeloma Study Group studyWaldenström’s macroglobulinemia (WM)NL-OMON27880Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data Center-CTCErasmus MC P.O. box 2040NL- 3000 CA RotterdamTel: +31 10 7041560Fax: +31 10 7041028e-mail: hdc@erasmusmc.nl72
已完成
2 期
A phase Ib/II study investigating the combination of RAD001 with trastuzumab and paclitaxel in patients with HER2-overexpressing metastatic breast cancer.10027656Breast cancerNL-OMON35692ovartis5